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Pharmaceutical Compositions of Metformin

a technology of metformin and composition, which is applied in the field of extended release dosage, can solve the problems of slow release rate, two difficulties are further compounded, and the formulation is difficult to provide a slow release rate, and achieves good reproducibility and adequate hardness

Inactive Publication Date: 2009-05-14
SIVA SATYA KRISHNA BABU PECHETTI +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0021]The object of the present invention is to prepare monophasic extended release pharmaceutical dosage forms of poorly compressible drug, metformin which will have adequate hardness and good reproducibility that releases the drug in a controlled manner over an extended period of time.
[0022]Another objective of the present invention is to provide monophasic extended release dosage form, which is uncoated, simple and economic.

Problems solved by technology

), which leads to difficulty in providing a slow release rate from a formulation and problems in controlling the initial burst of drug from such a formulation.
These two difficulties are further compounded by the high unit dose required for metformin hydrochloride.
This publication discloses a biphasic extended release dosage form comprising core and coating the core and provides for immediate release and extended release of the drug, which makes the process costlier and complex.

Method used

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  • Pharmaceutical Compositions of Metformin

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0049]

IngredientsQuantityMetformin HCl750 mg Magnesium Aluminum Silicate240 mg Xanthan gum60 mgCarbopol 971 P96 mgHydroxypropyl cellulose14 mgMagnesium stearate10 mgIPAq.s.Tablet Weight1170 mg 

example 2

[0050]

IngredientsQuantityMetformin HCl750 mg Magnesium Aluminum Silicate150 mg Xanthan gum60 mgCarbopol 971 P96 mgHydroxypropyl cellulose14 mgMagnesium stearate10 mgIPAq.s.Tablet Weight1080 mg 

[0051]The processing steps that are involved in examples 1 and 2 are[0052]i) sifted metformin HCl, magnesium aluminum silicate, xanthan gum, and carbopol 971 P through #40 mesh,[0053]ii) loaded the material of step (i) in RMG and mixed for 15 minutes,[0054]iii) dissolved hydroxypropyl cellulose in sufficient quantity of IPA:water[0055]iv) added the binder solution of step (iii) to dry mix of step (ii) and continued mixing until granules of uniform consistency were obtained,[0056]v) granules were dried, milled and lubricated,[0057]vi) granules of step (v) were compressed to form extended release tablets of metformin.

example 3

[0058]

IngredientsQuantityMetformin HCl750 mg Magnesium Aluminum Silicate240 mg Xanthan gum60 mgCarbapol 971 P96 mgPVP K9014 mgMagnesium stearate10 mgIPAq.s.Tablet Weight1170 mg 

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Abstract

The present invention relates to an extended release dosage form of highly water-soluble antidiabetic drug metformin or its pharmaceutically acceptable salts. This invention also relates to methods for preparing the extended release dosage forms of metformin or its pharmaceutically acceptable salts.

Description

FIELD OF THE INVENTION[0001]The present invention relates to an extended release dosage form of highly water-soluble antidiabetic drug metformin or its pharmaceutically acceptable salts. This invention also relates to methods for preparing the extended release dosage form of metformin or its pharmaceutically acceptable salts.BACKGROUND OF THE INVENTION[0002]Metformin hydrochloride is a biguanide derivative used as an oral antidiabetic. Metformin tablets are marketed under the trade name Glucophage and Glucophage XR (extended release).[0003]Metformin hydrochloride has intrinsically poor permeability in the lower portion of the gastrointestinal tract leading to absorption almost exclusively in the upper part of the gastrointestinal tract. Its oral bioavailability is in the range of 40 to 60% decreasing with increasing dosage, which suggests some kind of saturable absorption process, or permeability / transit time limited absorption. It also has a very high water solubility (>300 mg / m...

Claims

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Application Information

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IPC IPC(8): A61K31/155
CPCA61K9/2009A61K9/2054A61K9/205A61K9/2027
Inventor SIVA SATYA KRISHNA BABU, PECHETTIAMOL, KULKARNIASHISH, GOGIASIVAKUMARAN, MEENAKSHISUNDERAM
Owner SIVA SATYA KRISHNA BABU PECHETTI
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